DFG_5

CompletedPhase 1

The Role of Endogenous Glucagon-like Peptide 1 (GLP-1) in Type 2 Diabetes Mellitus (T2DM)

The Contribution of Glucagon-like Peptide 1 (GLP-1) to the Entero-insulinar Axis in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM)

Lead sponsor

Ludwig-Maximilians - University of Munich

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≤40•HbA1c ≤11%•Healthy volunteers

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01449019

Org study IDDPI

Timeline

Milestones

Study first posted2011-10-07estimated

Last update posted2011-10-07estimated

Study start2006-12 (month precision)

Primary completion2007-08actual (month precision)

Study completion2010-07actual (month precision)

Assets

Investigational agents

Avexitide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age30 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•male or female (postmenopausal, surgically sterile or using double-barrier method of contraception) healthy subjects and patients with type 2 diabetes mellitus (T2DM)

•must be able to complete a 1 week wash-out of current anti-diabetic medications

•Age 30-70 years

•HbA1c (Hemoglobin A1c) ≤11% at screening

•Body mass index (BMI) <40 kg/m2

•Patients with type 2 diabetes mellitus (T2DM): Must have a fasting blood glucose of ≤12.2 mmol/L (240 mg/dL) at screening

•Able to provide written informed consent prior to study participation

•Able to communicate well with the investigator and comply with the requirements of the study

Exclusion criteria

•Patients with type 1 diabetes mellitus (T1DM), diabetes as a result of pancreatic injury, or secondary forms of diabetes (eg Cushing, acromegaly)

•Need for insulin within the previous 3 months

•Use of Thiazolidinediones in the previous 4 weeks

•Significant concomitant disease or complications of diabetes (i.e. nephropathy, autonomic dysfunction, orthostasis).

•Treatment with systemic steroids and thyroid hormone (unstable dosage).

•Patients with any history of gastrointestinal surgery, e.g. partial bowel resections, partial gastric resections, etc.

•Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.

•Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.

•Significant illness within the two weeks prior to dosing.

•Past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.

•History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.

•history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;

•history or clinical evidence of pancreatic injury or pancreatitis;

•history or presence of impaired renal function as indicated by abnormal creatinine or urea val-ues or abnormal urinary constituents (e.g., albuminuria);

•evidence of urinary obstruction or difficulty in voiding at screening;

•Polymorphonuclears <1500/µL at inclusion or platelet count < 100,000/μL at screening and baseline.

•History of immunocompromise.

•Evidence of liver disease as indicated by abnormal transaminases and alkaline phosphatase exceeding twice the upper limit of the normal range, and serum bilirubin should not exceed the value of 27 µmol/L (1.6 mg/dL).

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.